Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma

Status: Temporarily Closed to Accrual

Description

This is a multi-center, single-arm, open-label, Phase 2 study of duvelisib, an orally bioavailable dual inhibitor of PI3K-δ,γ, in patients with CLL / SLL who have previously been treated with ibrutinib or another Bruton's Tyrosine Kinase Inhibitor (BTKi) and relapsed or were refractory to such therapy or discontinued such therapy due to toxicity.

Eligibility Criteria

Inclusion Criteria

  • ≥ 18 years of age.
  • Diagnosis of CLL or SLL.
  • Received at least one prior anti-cancer therapy for CLL or SLL.
  • Previous exposure to BTKi and meet at least one of the criteria below:
  • Progressive disease (PD) while receiving or within 6 months after completing BTKi therapy.
  • Discontinued a BTKi therapy due to BTKi treatment- related intolerance.
  • Measurable disease with a lymph node or tumor mass > 1.5 cm in at least one dimension.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Resolution of toxicities due to prior BTKi therapy to acceptable level.
  • Willingness of male and female patients to use medically acceptable methods of birth control.
  • Willing and able to participate in all required study evaluations and procedures.

Exclusion Criteria

  • Richter's transformation or prolymphocytic leukemia
  • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
  • Received prior transplant
  • Experienced PD or serious adverse events on a prior phosphoinositide-3-kinase (PI3K) inhibitor
  • Known central nervous system involvement by CLL/SLL

Locations & Contacts

See trial information on ClinicalTrials.gov for a list of participating sites.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Verastem Inc

Trial IDs

Primary ID VS-0145-224
Secondary IDs NCI-2018-02003
Clinicaltrials.gov ID NCT03370185